Clark W, Jobanputra P, Barton P, Burls A The clinical and cost-effectiveness of anakinra for the treatment of rheumatoid arthritis in adults: a systematic review and economic analysis. Health Technol Assess. 2004 May;8(18):iii-iv, ix-x, 1-105. Review.
FitzGerald GA, Patrono C The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med. 2001 Aug 9;345(6):433-42. Review.
Hengge UR, Brockmeyer NH, Goos M Granulocyte colony-stimulating factor treatment in AIDS patients. Clin Investig. 1992 Oct;70(10):922-6.
Hidalgo, M A., Romero, A., Figueroa, J., Cortés, P., Concha, I. I. Hancke, J. L. &. Burgos, R. A. Andrographolide interferes with binding of nuclear factor-kB (NF-kB) to DNA in HL-60-derived neutrophilic cells. British Journal of Pharmacology 2004. Jan; 141(2): 311-21.
Smolen JS, Steiner G Therapeutic strategies for rheumatoid arthritis. Nat Rev Drug Discov. 2003 Jun;2(6):473-88. Review.
Topol EJ Failing the public health--rofecoxib, Merck, and the FDA. N Engl J Med. 2004 Oct 21;351(17):1707-9. Epub 2004 Oct 6.
Yamamoto Y, Gaynor RB Therapeutic potential of inhibition of the NF-kappaB pathway in the treatment of inflammation and cancer. J Clin Invest. 2001 Jan;107(2):135-42. Review.
Yazici Y, Erkan D, Paget SA Monitoring by rheumatologists for methotrexate-, etanercept-, infliximab-, and anakinra-associated adverse events. Arthritis Rheum. 2003 Oct;48(10):2769-72.
Yazici Y, Erkan D, Paget SA Monitoring methotrexate hepatic toxicity in rheumatoid arthritis: is it time to update the guidelines? J Rheumatol. 2002 Aug;29(8):1586-9. Review.
Clinical Phase II Pilot Study of the Efficacy of FANG(30) to Treat Active Rheumatoid Arthritis in Adult Patients
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
